DYSPORT clostridium botulinum type A toxin

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Clostridium botulinum type a toxin haemagglutinin complex, Quantity: 125 U

Saadav alates:

Ipsen Pty Ltd

INN (Rahvusvaheline Nimetus):

Clostridium botulinum type a toxin haemagglutinin complex

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: Albumin; lactose monohydrate

Manustamisviis:

Intramuscular

Ühikuid pakis:

1 vial, 2 vials

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Dysport is indicated for symptomatic treatment of focal spasticity of: ? Upper limbs in adults ? Lower limbs in adults ? Upper limbs in children aged 2 years and older ? Lower limbs in children aged 2 years and older,Dysport is indicated in adults for the treatment of: ? Spasmodic torticollis ? Blepharospasm ? Hemifacial spasm ? Moderate to severe glabellar lines and / or lateral canthal lines (crow?s feet)

Toote kokkuvõte:

Visual Identification: White lyophilised powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2015-10-28

Infovoldik

DYSPORT
®
_(Clostridium botulinum type A toxin-haemagglutinin complex)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dysport. It does not
contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Dysport
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS DYSPORT
Dysport is a muscle relaxant
produced by Clostridium botulinum
bacteria. It acts on the junctions
between the nerves and muscles,
preventing the release of one of the
chemical messengers called
acetylcholine from the nerve endings
that would normally cause the
muscle to contract. If the messenger
is prevented from being released this
results in a weakened muscle and
helps to reduce some of the abnormal
muscle contractions.
WHAT DYSPORT IS USED
FOR
Dysport is used for the treatment of
•
upper limb spasticity in adults.
Upper limb spasticity is an
increased stiffness in the arm and/
or hand muscles that develops in
many patients after a stroke, for
example, and can lead to
restricted use of the arm or hand.
•
lower limb spasticity in adults.
Lower limb spasticity is an
increased stiffness in the leg and/
or foot muscles that develops in
many patients after a stroke, for
example, and can lead to
restricted use of the leg or foot.
•
spasmodic torticollis in adults.
Spasmodic torticollis is where
there is a turning movement of
the neck leading to an unusual
head and shoulder position
•
upper and lower limb spasticity in
children (2 years of age and
older) which may be due to
cerebral palsy. Cerebral palsy
spasticity is a disorder in which
some muscles become stiff and
movement is difficult
•
blepharospasm or hemifacial
spasm in adults. Blepharospasm
is a condition affecting the eye lid
muscles c

Toote omadused

Dysport Product Information: Version 8, 20 October 2021
1
AUSTRALIAN PRODUCT INFORMATION
DYSPORT
_CLOSTRIDIUM BOTULINUM_ TYPE A TOXIN - HAEMAGGLUTININ COMPLEX
POWDER FOR INJECTION VIAL
1
NAME OF THE MEDICINE
_clostridium botulinum_
type A toxin - haemagglutinin complex
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DYSPORT Powder for Injection contains 125, 300 or 500 IPSEN UNITS per
vial of
_clostridium botulinum_
type A toxin-haemagglutinin complex, 125 microgram human serum
albumin and 2.5 mg lactose in a sterile, lyophilised form without a
preservative.
ONE IPSEN UNIT is not equivalent to ONE UNIT of any other botulinum
toxin preparation.
From now on in this Product Information the term Ipsen unit will
simply be replaced by the
term unit.
_Clostridium botulinum_
type A toxin-haemagglutinin complex has a molecular weight of about
900,000D and is a complex of proteins.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DYSPORT 125U, 300U, or 500U is a white lyophilised powder for
injection in a clear glass
vial
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dysport is indicated for symptomatic treatment of focal spasticity of:
•
Upper limbs in adults
•
Lower limbs in adults
•
Upper limbs in children aged 2 years and older
•
Lower limbs in children aged 2 years and older
Dysport is indicated in adults for the treatment of:
•
Spasmodic torticollis
•
Blepharospasm
•
Hemifacial spasm
•
Moderate to severe glabellar lines and / or lateral canthal lines
(crow’s feet)
Dysport Product Information: Version 8, 20 October 2021
2
4.2
DOSE AND METHOD OF ADMINISTRATION
THE UNITS OF DYSPORT ARE SPECIFIC TO THE PREPARATION AND ARE NOT
INTERCHANGEABLE WITH OTHER PREPARATIONS OF BOTULINUM TYPE A
TOXIN.
TRAINING
: DYSPORT should only be administered by appropriately trained
physicians. The
product distributor can facilitate training in administration of
DYSPORT injections.
_FOCAL SPASTICITY AFFECTING THE UPPER LIMBS IN ADULTS _
Dosing in initial and sequential treatment ses